Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos

This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality management system (QMS) pathways.
Alex and host Etienne Nichols discuss the immense value of having a diverse internal team of consultants to draw from—a collective knowledge base that helps solve complex problems for clients. They emphasize that quality professionals don't need to know "everything" but rather must have the right resources and a "beginner's mindset" to guide companies effectively. The conversation also explores how modern software, like Greenlight Guru's QMS and EDC solutions, eliminates common industry pain points, such as fragmented, error-prone spreadsheet-based design controls by building true, linked traceability directly into the eQMS.
Finally, the discussion touches on the philosophical "why" of the medical device industry: the patient. Alex shares a personal story about how orthopedics improved his grandfather's quality of life, underscoring the importance of maintaining a patient-first ethos. They conclude by discussing the upcoming QMSR transition, reassuring listeners that compliance is manageable, especially for those already adhering to ISO 13485.
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Key timestamps
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[01:50] Alex Naber's MedTech Career Path: From Bioengineering to Design Quality and Post-Market Management.
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[04:30] The Power of Pooled Expertise: Why Greenlight Guru's Consultant Team is a "Sherpa up the mountain."
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[07:35] The Problem with Spreadsheets: Comparing traditional Design Control methods to modern eQMS traceability.
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[11:00] Accelerating Compliance: How Greenlight Guru's QMS Templates dramatically cut implementation time.
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[13:30] The Bloated QMS: Why adopting procedures from large corporations may hinder small-to-midsize companies.
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[16:00] Design Quality Explained: Marrying R&D/Product Development with QMS compliance.
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[21:30] The MedTech Ethos: Focusing on the patient and improving quality of life.
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[27:00] CAPA Management Insights: The critical distinction between Correction and Corrective Action.
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[30:25] Navigating the QMSR Transition: Reassurance that compliance isn't "that deep" if you are already ISO 13485 compliant.
Top takeaways from this episode
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Seek a Unified Quality Solution: Fragmented quality processes (e.g., design controls in spreadsheets separate from the QMS) introduce significant regulatory risk. Adopting an eQMS, like the Greenlight Guru QMS solution, creates true traceability and dramatically streamlines compliance.
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Design Quality as a Partner, Not Police: Design Quality Engineers should actively partner with R&D, not just enforce rules. This involves educating product development teams on the why behind documentation and regulations to collaboratively find compliant solutions.
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Implement CAPA Early and Correctly: A robust CAPA process is essential long before market entry. Quality professionals must know the difference between a correction (fixing the immediate issue) and a corrective action (addressing the root cause) to prevent systemic non-conformances.
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Leverage QMS Templates for Speed: For new or growing companies, utilizing pre-validated QMS templates, like those offered by Greenlight Guru, can cut months off the time required to establish a 13485 or FDA CFR Part 820/EU MDR compliant system.
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QMSR is Not Overwhelming: As the QSR evolves into the Quality Management System Regulation (QMSR), companies already adhering to ISO 13485 will find the transition is relatively minor, primarily requiring minor updates rather than a complete overhaul of their existing QMS.
References:
- Alex Naber's LinkedIn
- Etienne Nichols' LinkedIn: Connect with Etienne
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ISO 13485:2016: The international standard specifying requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Relevance: This is the foundation for managing QMS changes, including the QMSR transition.
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Quality Management System Regulation (QMSR): The upcoming modernization of the FDA’s Quality System Regulation (21 CFR Part 820), harmonizing U.S. requirements with ISO 13485. Relevance: The central regulatory change discussed at the end of the episode.
MedTech 101 Section
Design Quality: In the medical device industry, Design Quality (DQ) is a specialized function within the Quality Assurance (QA) department. Its role is to ensure that the process used to design and develop a new medical device is compliant with the company's QMS procedures and applicable regulations (like FDA 21 CFR Part 820 or ISO 13485). Think of Design Quality as the engineer's compass and map for compliance—they guide the R&D team to make sure every requirement, test, and risk mitigation is properly documented and linked, preventing costly issues down the line. Without DQ, R&D teams might build a great product that can't be legally sold.
Correction vs. Corrective Action: These two terms are often confused in quality management:
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Correction: The immediate action taken to fix a non-conforming issue. Example: A batch of surgical instruments has burrs, so the correction is to re-polish them.
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Corrective Action (CAPA): A deeper, systemic action taken to eliminate the root cause of a non-conformance so it does not happen again. Example: The corrective action is revising the manufacturing work instruction to include mandatory daily calibration of the machine causing the burrs.
Memorable quotes from this episode
"It's a rewarding thing to just understand that you don't need to know everything. I think that's a thing that... people should realize and they should reach out to other people that are smarter or more experienced in realms that they don't understand." - Alex Naber
"I think what got me into MedTech was more of the ethos behind it... We're creating products to make patients' lives better, to impact our world, our society in a positive manner, to give a better quality of life to individuals." - Alex Naber
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Sponsors
This episode of the Global Medical Device Podcast is brought to you by Greenlight Guru, the only MedTech-specific platform that provides both a powerful Quality Management System (QMS) and industry-leading Electronic Data Capture (EDC) solutions. Alex Naber, an expert consultant from Greenlight Guru, highlights in this episode how integrating your design controls—the subject of his design quality expertise—directly into a compliant eQMS is the key to accelerating product development, eliminating audit anxiety, and truly improving the quality of life for patients. To learn more about how Greenlight Guru's dedicated solutions can streamline your path to market, visit www.greenlight.guru.
Transcript
Etienne Nichols: Hey, everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. And today, a little bit less problem solving. We're going to actually be talking and interviewing a colleague of mine, Alex Naber, who is a medical device consultant internally here at Greenlight Guru helps companies understand the regulations and the pathways they need and really just understand what is it that I even need to do to implement a QMS and a few other things. I won't butcher the intro, but, Alex, how are you doing today? Good to have you with us.
Alex Naber: Good. I'm doing really well. I'm happy to be here for him to be here.
Etienne Nichols: Do you want to let. Why don't we go through? Because I want this episode to be something of a. We have a historic tradition of a meet the Guru episode where when we had a new.
What we used to call them as medical device gurus, we would. We would introduce them and we'd kind of give their background so that people knew a little bit more about the experience that we have internally here at Greenlight Guru.
So that we want to be the trusted voice in MedTech. We want to be the ones who can lead you up the mountain, kind of like that Sherpa up the mountain.
So, as you're taking your medical device to market, so why don't we go into your background a little bit and talk about where you've been, where you come from, what your aspirations are?
Alex Naber: Yeah, absolutely. Yeah. So went to my university, Oxford, Ohio. Was the part of the second graduating class of bioengineering there. It was a very new degree when I was going through there.
Started as a complaint engineer with an orthopedic company called Biomed at the time, which bought Zimmer.
I'm sorry, which Zimmer bought as soon as it became Zimmer Biomet.
Lived in Warsaw two and a half years. Loved it. Cool little town.
But wanted to be closer to a. I don't know, a larger airport, be able to travel a little bit easier. So decided to apply to our spine organization out here in Denver, Colorado, which I live in Louisville, Colorado now, but worked for our spine company for about five years.
Started as a field action specialist, engineer, kind of doing health hazard evaluations, determining the need for field actions, as well as investigating complaints as well. Still, eventually Got into design quality and so helped on some of our new, our new projects. Worked on a device called the Tether for a little while.
Very, very cool. Dev helps adolescent scoliosis patients.
Very, very rewarding. And then became a quality manager and headed up the post market side of our spine division for a couple years and then eventually about three years ago, joined Greenlight.
And have loved it, have loved the team, loved the environment, like being able to work with a variety of companies and people.
And like you said, we've got a great background of experience on our, for our, our medicalized gurus here, medical consultants, what have you.
We have a huge variety, which is, which is always nice.
Yeah.
Etienne Nichols: And, and what I love about that is you have a pool of knowledge to draw from. I remember when I was working as a medical device guru myself, I would face things and it's intimidating because, you know, I don't know, how many companies do you think you've worked with in the last three years for Greenlight Guru?
Alex Naber: Oh, man, I'd say probably over 200. Wow. Yeah, just not, not on a recurring basis, but just like ancillary, like ad hoc calls in addition to that.
Etienne Nichols: Yeah. Answering questions, solving problems.
Alex Naber: Yeah, absolutely. Well, I was or could be on a guru assist as well.
Etienne Nichols: I think I was somewhere in the 50 to 60 range. And it was intimidating because those were my recurring calls that I had to, you know, monthly or bi-monthly or whatever it was.
And I just, I thought, okay, I don't know everything. And it was explained to me, well, wait, you don't need to know everything. You have this team that you can draw from.
This guy's got combination product experience. This one's a project manager and Kappa manager, whatever else. So that is super, super helpful. It's a one point of contact, but lots of, lots of knowledge behind that point of contact.
Alex Naber: Absolutely. And I think, honestly, I think it's a rewarding thing to just understand that you don't need to know everything.
I think that's a thing that I don't know even within our, within the medicalized industry that people should realize and they should reach out to other people that are smarter or more experienced in realms that they don't understand to gain that level of experience or.
Yeah, just gain that level of knowledge. I think it's rewarding to say, I don't know, let me go find that out for you.
Etienne Nichols: Absolutely. And I mean, that really is the key. You say that and then you go find it out, you get the answer and they're happy. I always described what did a.
Because people would ask me what is a medical device guru at Greenlight Guru? What's, what's, what's that entail? And I would just kind of describe it. It might be a little bit, I don't know, abstract, but I would say you have to have medical device experience of some sort. So, you've worked in the medical device industry, you have the heart of a teacher, you are ready to teach and a beginner's mindset. You recognize that you don't know everything. So those three things are pretty critical.
Alex Naber: Yeah, 100% agree with that. 100% agree with that. It's a matter of trying to guide, teach, mentor to either new people that are new to the industry, that don't necessarily know what they don't know yet, they don't know what they need to do yet and, or just help people with our product as well. That's another item. If people are more experienced in the industry, then it's a matter of helping them get to know like our products, best practices, things like that.
So, industry knowledge as well as product knowledge is really where it kind of goes.
Etienne Nichols: And when I came to Greenlight Grid, I don't think I recognized what all the product entailed. You know, I'd worked in quality management systems before SAP, Oracle, R12, Agile, I think were I worked with the really big stuff, but design controls was in spreadsheets. And so, when I came, you know, I knew Greenlight grew as a QMS, so that's what I was expecting. But, but inside that QMS is a product development playground as well for anyone who has to manage design controls.
And I really, I target the project managers. I think, man, this will make your life so much easier. But I don't know if you want to speak to some of that, how some of this software can help a medical device company and the people working there.
Alex Naber: Yeah, absolutely. Yeah. I mean so my last company, we use Excel spreadsheets, which I think is kind of like the typical standard within the industry of if you're building a traceability matrix, whether that be design control traceability or risk traceability and they, they're highly configurable, they're easy to use.
However, you don't get like you're always going to have references for like either what are your design outputs, what are your verification items, what are your validation items and or what are your risk mitigation items.
Like you will include references to those where you'll have to.
Etienne Nichols: True traceability.
Alex Naber: Right, exactly. Not true traceability. You got to like just be like, oh, here, this, this is the call out for it and then you got to go find it and you got to hope, hope that reference is still accurate.
Maybe there might be a change that you accidentally forgot to do or something like that. But the lovely thing about the within Greenlight is that you're building it. You're building those, linking those linkages, those TRA, that traceability directly within your eQMS.
So, you identify this is the item that was created, this was the design output, this is the risk mitigation item, the risk control, here's a link for it and you immediately go access it instead of having to go to another location to a software while, while having your spreadsheet pulled up.
So, it just makes that connection, that traceability a lot faster and a lot easier to navigate.
Etienne Nichols: I love that. And you know, now with our new product Ultralight it's, it even extends that a little bit further. So, if you have your GitHub or your Jira items, you can lift those in easily and you have all of your software elements, repositories.
So, on this, that's, yeah, that's, that's really exciting to see what's changing in the industry, what's changing internally at Greenlight Guru, what the future will be. And before we got on we were talking a little bit about another thing that you do, I guess I don't know if we call a side project.
I don't know how many hats you wear, Alex, but I know the templates are another thing and those are a huge value add to people who come to Greenlight Guru.
Can you speak to that a little bit?
Alex Naber: Yeah, absolutely. So, I manage our templates here, our QMS templates here at Greenlight Guru we also have a software template package that Rook or one of our partners manages. But the QMS template package is a, it's a QMS that you can stand up very rapidly. Basically, we have the documentation, we've got the procedures, work instructions, work forms that you would need to build a 1345, ISO 1345 or FDA CFR part date 20 or EUMDR compliant QMS.
We've got the documentation to help you build that.
Just go ahead and just stand up those documents immediately within your QMS there might be require some tweaks here and there, but they are ready made and easy to implement so that you don't have to build them yourself, which can take hours and weeks of and maybe even months of time to just build them from scratch.
So, we cut out all of that time that you would be deliberating on what should go here, what should go there, what procedures do I need, what do I not need?
We create all of those procedures for you. Yeah.
Etienne Nichols: And I was talking to somebody recently, I don't know last week or what exactly, but someone who had their friend was going to provide them with SOPs who had worked either at Boston Scientific, Johnson, John, whatever.
And that's the, the industry is a little bit incestuous in that regard. So first of all, aside from the ethical, you know, taking those documents from the company was that aside, there's a good chance those SOPs are extremely bloated. You know, absolutely 50-page quality manual when it doesn't need to be that. So many different things. So, starting just with the streamline, put your stuff in, you're not taking this out.
Taking a spine specific something out when you're neurological. I don't know.
Alex Naber: Yeah, yeah, a hundred percent. A hundred percent. I know my last company, I at large global company, I had about 200 documents that I trained on. That was my annual training plan. I even.
Am I to kill your spirit? Yeah, yeah, exactly. My last role actually I, because I was managing teams across two different QMS’s, across two different departments or organizations within Zimmer Biomet.
Eventually I think it got up to closer to like 2:50, 300 just because there was overlap in some procedures but not everything.
So, a lot of documentation. So, like you said, it can be a bloated QMS.
These procedures are, I would say they'll get you started, they will meet the requirements, meet the 13 per guide requirements and you might need to add some additional content here and there based upon your device.
However they're going to be able to, they're established to meet the regulations and standards that you would need to.
Etienne Nichols: Yeah. And I will say, you know, when we talk about those bloated QMS’s, they could be just fine for the companies that are that size. But if you're not the size of Zimmer Biomet or if you're not the size of jj, whoever it is, it just may not be the one.
So, the other thing I would say is I like that you said it is a QMS because that is a misunderstanding in the industry.
What is an eQMS? What is a QMS?
And you know, we've talked about that a little bit in the podcast before with a few other different gurus that I've had on the podcast, but I think that's an important delineation as well.
Alex Naber: Absolutely, absolutely.
Etienne Nichols: Yeah.
Alex Naber: The QMS is the documentation where you,
if you're housing and electronically on a software solution like Greenlit Guru, it becomes an eQMS which is so much easier to manage because you don't have to worry about signing off on documents, running it around through the office setting or even mailing it to someone.
Not mailing, but it's not a snail mail back emailing to someone, having them sign off on it and then print it out, sign off on it. So yeah, that eQMS platform is absolutely the way to go in terms of collaboration, ease of use.
Etienne Nichols: So, I'm want to dive a little bit more into your background a little bit because you said product, what was it? Product quality?
Design quality. That's what it was.
Alex Naber: Design quality.
Etienne Nichols: Yeah. You were working on design quality. Can you explain a little bit about that? Because I think a lot of people see design and R&D may even be upstream of product development and then you have quality over here by themselves.
In between. Is this friction oftentimes. But what's your experience?
Alex Naber: Yeah, absolutely. And I would say so again, I worked for a large company. We had different silos of quality, several different ones just because as a large organization, so people become specialized.
That's just, that's just what happens. Large organization. But my role was to sit on design project teams and ensure that we are meeting our procedures, we're following our procedures, going along with how we should be designing our product, what documentation we are creating, how we are performing, verification, validation, testing, making sure everything's appropriate.
So, my role is really to kind of marry, I don't know, be that, be that person that helps the design, the design project become compliant to our quality management system.
Etienne Nichols: Yeah, yeah, that makes sense. And you know, a lot of companies will, that will be an unofficial job of the project manager who absolutely. Or the lead engineer or whoever else.
And so, I like that it's, it's kind of designated there, but I do think there's a lot more education that needs to happen with project managers and so on because that, that's actually how I found Greenlight crew.
I was a, I was, I got my PMP. I was working on a project management role for a drug delivery combination product and there were. I kept having to teach design controls to the engineers.
And I think, you know, you can make it a lot simpler than we feel like it has to be sometimes. And so anyway, I think that is an important role.
It's an under under.
It's an unsung hero type role.
Alex Naber: It is. There was a joke where sometimes I felt like a traffic cop at times. We're like, we have to make sure we're doing it this way.
But you.
I've had, I've had engineers over the years or like design, design engineers over the years, the product development engineers that wanted to ensure they're trying to make a product. They want to make the product, they're passionate about it and sometimes is like you said,
they just don't unders. They didn't understand the quality, the why behind some of the documentation we had to create or why we do things a certain way. And I think it's a matter of necessarily just being a traffic.
I'm saying stop. No, you can't do it this way more. Let's work with them, educate them on what the need is, what the requirements are, what a procedure they're saying and regulations are saying,
and how can we work with them, how can we quality work with design and development to find a solution that gets us there.
Etienne Nichols: Yeah.
I had a, I had a guy early in my career say something similar. He said equality can be a, they can be a police or they can be a partner.
And we want to be a partner. So.
Alex Naber: Absolutely.
Etienne Nichols: It's a good way to look at it. Yeah. What's your favorite part about Medtech? If you were to just look, you know, the regulations are big, ISO 1345, you flip it over.
What's. What would be your favorite part of MedTech, do you think?
Alex Naber: I think what got me into MedTech was more of the ethos behind it was like the.
We're creating products to, to make patients’ lives better, to impact our world, our society in a, in a positive manner, to give a better quality of life to individuals. I, I got into it.
It's my, my grandpa had. Had double knee replacements when I was young and younger.
And I know that they helped his quality of life. It's part of the reason I wanted to get into orthopedics, honestly. They allowed him to get to, to go to like games that, that I was having. So, like go to my baseball games, go to my basketball games, allow him to just kind of be there, which he wasn't.
Might not have been able to move, get like move around. He actually drove until he was like 91, I think something like that, which was a bit shocking. But he, he was awesome. And like I said, that kind of ethos of we're trying to help our community in a positive way, I think is the.
What brought me to it and I think is hard to remember sometimes when you're in like the quality documentation side of things, like what's the, what's the reason we're doing this and that. That's making sure we're. We've got the patient in mind. Yeah, yeah.
Etienne Nichols: I think that's important for any company in the health or medical device space is to really remember the patient because it does bring it home. The ethical side of things, for sure.
There's different ways you can do that. You can invite a customer who's really believed in your product, you know, to come speak at your all hands event or whatever. Yep.
Alex Naber: Very, very common. Always loved all of those types of things where like we'd either have like a surgeon come in or maybe we've had a patient come in who. I remember I was talking about the tether earlier.
It's this company, it's this product that my last company was making now. Now it's High Ridge Medical at this point. They've a few different name changes over the time, but basically, they help adolescent patients with scoliosis.
The way that they do that instead of having a fusion, this tether cord gets put into place using some screws. It gets tightened to help reduce the curvature of the patient's spine.
But as they grow, it's supposed to, because of the compression that's putting on the discs, they will naturally kind of grow out of the curvature of their spine. They.
So that it, it helps over time. But we had a patient come in who was super active, was playing like water polo like a few years after having the procedure.
It was so cool. But having that was, I think always important.
Like knowing your. Why.
Etienne Nichols: Yeah, I think that is important. And, and there's lots of ways to do that. And you can tie it to the quality side too, that I, we talked about the quality being received as a police every now and then or traffic cop. And if you.
I was actually talking. I don't know who this was. I keep thinking I need to start learning, remembering who I talk to. But when it comes to positives and negatives, you know, risk management in general, I was, I know who it was.
I was telling one of our salespersons is, you know, risk management in general is a. It feels like a cost sync. Okay, we're going to mitigate all these risks.
But if you don't actually ever see those risks, you feel like, man, we just spent a hundred thousand dollars. You know, would it have actually happened or not? But if you fix an existing problem, like you save somebody's life who is in emergent danger. Well, you've done Something amazing. So, there's the positive and negative, two different levers in my mind.
And so, I do think it's important to understand or convey if we don't do it this way, these are the potential impacts and actually have that graphic image. You know, this is maybe a competitor, maybe someone else who they didn't have this stuff in place and here it is.
You know, this is what could happen if we don't do the things that we expect are, you know, our engineers to do.
Alex Naber: Yeah, absolutely, absolutely. Have that. That again, that. Why?
Etienne Nichols: Yeah.
Alex Naber: What, what is the impact of your current role? What's the impact of your job on making sure these patients like these people are going to have a better quality of life or not be impacted negatively.
Buyer product.
Etienne Nichols: So CAPA management, we've talked about that a lot. It's one of the top three reasons for FDA four 83s every single year.
How did that go and what were your thoughts when you were, you said you were a Kappa manager at one point, right?
Alex Naber: Yeah, so I, I managed our issue evaluation process which was basically kind of like a precursor to CAPA. Basically, they fit required, it was more quality process related items. So instead of having like a non-conformance that we had open, we'd open an issue evaluation. That's just how our system was.
But if it had a correction, it would stay within the, within the issue evaluation realm. If it had ended up having to get into corrective action, it would, it would go into CAPA, it would be open into there.
But highly important one.
I think knowing the distinction between correction and corrective action is a, is something that isn't always known where correction is correcting the issue that occurred and corrective action is addressing that root cause of the issue, changing procedure or changing our process, changing our workflow, something like that. But I'm not surprised that it's the most common thing I feel like it can be.
I don't know what I'm trying to say.
There's a balance, I think between opening a CAPA versus a non-conformance.
You don't want to overburden your quality management system by opening CAPA for every issue that comes up.
You don't want to under burden.
Is it systemic? Yes, absolutely. Absolutely. So, I think that's an important thing.
Etienne Nichols: Yeah, yeah, that's true.
I think some companies think, okay, we'll go ahead and put a procedure in place, we'll do CAPA’s when we get on the market. But I think that's a little bit of a mistake because you miss that Ramp up period to see if your cap is even working.
I mean, there's other issues too, you know, if you have ISO 1345 certification in mind and other things as well. But what are your thoughts on building that out from the beginning and doing it right?
Alex Naber: Yeah, I, I completely agree with that. I think it's a, some a system. It's a process that you should have implemented before going on the market.
One, it's going to need to be there before you get there. But like you said, it's good to have the, I don't know, the wrinkles ironed out of what, how your process is going to be managed, how it's going to flow, if you can.
I think it's a sign of a healthy quality management system. Your continuous improvement. You can identify, like, oh, this issue occurred instead of just fixing it. You can identify, okay, well, where are there some potential.
Where are the potential, the preventative actions that we can implement as a result of this? Like, okay, we're doing a similar thing over here or there. This could be something that could be mitigated over here, over here to prevent an issue going forward.
Yeah, exactly. Different product lines or different design control. Maybe you didn't define correctly. Maybe not correctly, but inadequately.
Like, oh, we defined this one here wasn't too great. Let's, let's go back and look at this other one that could be a little ambiguous as well. Something like that.
Etienne Nichols: That's a good point. Yeah, I think that's a good point.
Oh, cool. Well, I've enjoyed talking to you. Are there any things you'd like to just say to the audience? Any, any.
Anything you'd like them to go check out? I don't know. You know, it's anything you have the.
Alex Naber: Yeah. Appreciate you.
I enjoy what I do. I enjoy helping our customers gain a better understanding of our products as well as just the regulations in general.
I think there is.
The QMSR is upcoming. QSR releases upcoming in February.
To quote Taylor Brown, it's not that deep.
I don't like. Yes, there's things that are changing, but if you're meeting ISO 1345 already, there's not gonna be drastic changes that are happening to your QMS.
Highly recommend reading through the regulation, the rule, the actual QMSR rule. You'll notice that the very bottom of the QMSR is the new part 820.
Take a look at that.
Basically, that's where the FDA is defining. Okay, you have to do these things.
Otherwise, it's 1345, 28, 2016.
So yeah, not too much else.
Enjoy the conversation. Thank you so much for having me.
Etienne Nichols: Well, I would say to the audience listening if you are freaking out about QMSR, it would be nice if you want to work with somebody who recognizes that it's going to be a blip, it's going to be okay.
We got this. No worries. I do the templates.
I work with. You've said 200 plus companies.
I recognize the pitfall, the different things.
Head over to www.greenlight.gouru Absolutely. And check out our software, product development, quality management system, clinical solutions. You know, we our goal is to really be the service provider that can help a medical device company bring their company bring their medical device to market and improve the quality of life.
Alex Naber: So, we've got some great webinars on this on that topic as well. Highly recommend. Recommend listening to this podcast if you do it regularly, if they don't already.
Etienne Nichols: Yeah, if this is the only one you need to listen.
Alex Naber: Yeah.
Etienne Nichols: Cool. Really appreciate it. Alex, those you've been listening, thank you so much for listening to the Global Medical Device Podcast. We'll let you all get back to the rest of your day until next time. Take care.
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About the Global Medical Device Podcast:
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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...


